Carcinomatous or Polymorphous Skin Lesions
Conditions
Brief summary
Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ? A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection: * In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma, * In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.
Interventions
DEVICEbimodal optical spectroscopy
an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra
Sponsors
Centre Hospitalier Régional Metz-Thionville
University of Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, and * Autonomous: enjoying full citizenship rights and full mental abilities, and * Affiliated to a social security system, and * Suffering from carcinomatous or polymorphous skin lesions that can be fully managed in an outpatient (ambulatory) surgery procedure.
Exclusion criteria
* Carcinomatous or polymorphous skin lesions that require day admission, or * Carcinomatous or polymorphous skin lesions for which resection margins are uncertain, or * Naevomatous skin lesions and related skin pathologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optical spectroscopy's diagnostic validity for the 4 histological classes discrimination | day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between in situ carcinoma (ISC) and invasive carcinoma (InvC). | day 1 |
| Statistical significance degree of the discrimination by molecular profiling (transcriptomic characterization) between 2 classes of actinic keratosis (AK) of clinical relevance: AK characterized by a "low" versus a "high" invasiveness risk | day 1 |
| - Sensitivity and specificity of optical spectroscopy for discriminating the é molecular classes of actinic keratosis: AK characterized by a "low" versus a "high" invasiveness risk. | day 1 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGrégoire Khairallah
g.khairallah@chr-metz-thionville.fr
Outcome results
None listed